Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer

Completed · Phase 3

Conditions studied: Breast Adenocarcinoma, HER2 Positive Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7

In brief

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

Key facts

Study ID

NCT00005970

Run by

National Cancer Institute (NCI)

People needed

3436

Starts

2000-05-19

Expected to finish

2010-01-27

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Required tumor parameters for node positive disease: NOTE: This study will continue to use the American Joint Committee on Cancer (AJCC) 5th edition for TNM classification and staging
• Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes
• Node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by hematoxylin and eosin (H\&E)
• NOTE: Positive nodes refers to H\&E visible nodal metastases; immunohistochemistry (IHC) positive only cells in lymph nodes will not be considered positive nodes
• One or more positive lymph nodes whose tumors are T1-3, pN1-2, M0 are eligible
• cN2 disease is not eligible
• pN2 disease is eligible
• One positive lymph node by sentinel node biopsy or at least 6 axillary nodes must be examined on axillary node dissection with at least one positive lymph node
• Metaplastic carcinoma is eligible
• ER/PgR determination
• HER-2 positive (pre-entry requirement for registration)
• FISH must show gene amplification OR
• IHC assay must show a strong positive (3+) staining score
• NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification
• Required tumor parameters for high-risk node-negative disease; NOTE: This study will continue to use the AJCC 5th edition for TNM classification and staging
• Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes
• Node status may be determined by either axillary node dissection or sentinel node biopsy with H\&E staining; to be considered node negative, either of the following must be true: 1) negative sentinel node biopsy or 2) no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection
• NOTE: IHC positive only cells in lymph nodes will not be considered positive nodes
• Tumors > 2.0 cm (irrespective of hormonal receptor status) or > 1.0 cm if ER-negative and PR-negative disease
• ER/PgR determination
• HER-2 positive (pre-entry requirement for registration)
• FISH must show gene amplification OR
• IHC assay must show a strong positive (3+) staining score
• NOTE: DCIS components should not be counted in the determination of degree of IHC staining or FISH amplification
• =< 84 days from mastectomy or =< 84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure; (This timing is per a decision by the Breast Intergroup)

You may not qualify if…

• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, intrauterine device [IUD], surgical sterilization, or abstinence, etc.); hormonal birth control methods are not permitted
• Locally advanced tumors (classification T4) at diagnosis including tumors fixed to chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
• Prior history of breast cancer, except LCIS
• Bilateral invasive carcinoma, either metachronous or synchronous (EXCEPTION: Patients diagnosed with unilateral invasive carcinoma and metachronous or synchronous DCIS of the contralateral breast treated with mastectomy are eligible)
• Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
• Active, unresolved infection
• Active cardiac disease
• Any prior myocardial infarction
• History of documented congestive heart failure (CHF)
• Current use of digitalis or beta-blockers for CHF
• Any prior history of arrhythmia or cardiac valvular disease requiring medications or clinically significant
• Current use of medications for treatment of arrhythmias or angina pectoris
• Current uncontrolled hypertension (diastolic > 100 mmHg or systolic > 200 mmHg)
• Clinically significant pericardial effusion
• Prior anthracycline or taxane therapy for any malignancy
• Sensitivity to benzyl alcohol
• Neurology/Neuropathy-Sensory >= grade 2 per the National Cancer Institute's (NCI's) Common Toxicity Criteria Version 2.0; EXCEPTION: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair

Where it is running

• Western Regional CCOP — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Community Cancer Institute — Clovis, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Washington Hospital — Fremont, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Memorial Medical Center — Modesto, California, United States
• Community Hospital of Monterey Peninsula — Monterey, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Salinas Valley Memorial — Salinas, California, United States
• University of California San Diego — San Diego, California, United States
• Naval Medical Center -San Diego — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• The Angeles Clinic and Research Institute - Santa Monica Office — Santa Monica, California, United States
• Santa Rosa Memorial Hospital — Santa Rosa, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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